FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000

• K Number: K993046
• Device Name: FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
• Manufacturer: FIBRA SONICS, INC.
• Date Cleared: 1999-11-22 ( 73 days)
• Product Code: FEO
• Regulation Number: 876.4480
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: N/A

Intended Use

The Fibra Sonics LithoSonic Model LS-2000 Ultrasonic Lithotripsy System is intended to fragment urinary calculi in the kidney, ureter, and bladder.

Device Description

Not Found

AI/ML Overview

This document is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study details (sample size, provenance, expert qualifications, adjudication), MRMC studies, standalone performance, or training set details. It is a regulatory approval document, not a study report.

Regulation Number and Section

§ 876.4480 Electrohydraulic lithotriptor.

(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”